Thursday 20 October 2016

WHO guidance on variations to multisource pharmaceutical products

The World Health Organization has updated Annex 10 of its GMPs “WHO general guidance on variations to multisource pharmaceutical products.”

According to the document:

“A marketing authorization (MA) holder or applicant is responsible for the quality, safety and efficacy (QSE) of a finished pharmaceutical product (FPP) that is placed on the market, throughout its life cycle. After the FPP has been authorized for marketing, the manufacturer will often wish to make changes (variations) for a number of reasons, for example, to respond to technical and scientific progress, to improve the quality of the FPP, to apply updates to the retest period for the active pharmaceutical ingredient (API) or shelf life of the FPP, to meet market requirements such as for scale-up or additional manufacturing sites, or to update product information (e.g. the information on adverse reactions). Such changes, regardless of their nature, are referred to as variations and may require the approval of the national medicines regulatory authority (NMRA) prior to implementation.”

The document can be accessed here.

Posted by Dr. Tim Sandle

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